FDA.reportPublic FDA data

ZEP ROUND ONE AB

Manufacturer
Zep Inc.
Effective date
2020-11-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:06:37

Label at a glance#

ProductZEP ROUND ONE AB
Active ingredientCHLOROXYLENOL
Label structure13 sections

Indications and uses

Hand washing to decrease bacteria on skin

Dosage and administration

Wet hands with water. Place hands under dispenser and apply liquid soap. Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles. Rinse hands thoroughly and dry.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.4%

OTC - PURPOSE SECTION

Antiseptic Handwash

Uses

INDICATIONS & USAGE SECTION

Hand washing to decrease bacteria on skin

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use in or around the eyes.

When using this product

OTC - WHEN USING SECTION

  • If eye contact occurs, rinse promptly and thoroughly with water.
  • Do not swallow.
  • If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation or redness persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children except under adult supervision.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands with water.
  • Place hands under dispenser and apply liquid soap.
  • Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles.
  • Rinse hands thoroughly and dry.

OTHER SAFETY INFORMATION

  • Do not freeze.
  • Dispose in accordance with all applicable federal, state and local regulations.

INACTIVE INGREDIENT SECTION

Water, Sodium C14-16 Olefin Sulfonate, Pumice, Cocamidopropyl Hydroxysultaine, Stearic Acid, Methacrylic Acid Copolymer, Attapulgite, C11-13 Pareth-6, PEG-75 Lanolin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Glutaral, Titanium Dioxide, Palmitostearic Acid, Orange 7, Yellow 5

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-I-BUY-ZEP (1-877-428-9937)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Round OneRound One

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66949-30966949-309-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
PALMITOSTEARIC ACIDQ8Y7S3B85MIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
PUMICENT5NN5KL16IACT
ATTAPULGITEU6V729APAMIACT
PEG-75 LANOLIN09179OX7TBIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
GLUTARALT3C89M417NIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
DIPOTASSIUM 4',5'-DIBROMOFLUORESCEIN3T0760MA5AIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
STEARIC ACID4ELV7Z65APIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
C11-13 PARETH-6G892LZ1790IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CHLOROXYLENOL0F32U78V2QACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b4646f8f-0373-6a0e-e053-2a95a90a542c5be9dae7-5982-5ae2-e053-2a91aa0ad24d2020-11-18WarningsExact identifier
spl id: b4646f8f-0373-6a0e-e053-2a95a90a542c
spl set id: 5be9dae7-5982-5ae2-e053-2a91aa0ad24d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.